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Completed

NCT Number: NCT04131842

External Versus Internal Feedback in Patients With Chronic Ankle Instability

Although altered biomechanics has been well documented as an impairment associated with chronic ankle instability (CAI), effective interventions targeting biomechanics with long-term outcomes measuring patient-reported outcomes (PROs) are absent. Evidence suggests that external focus of attention (ExFOCUS), internal focus of attention (InFOCUS) feedback, and auditory feedback during movement training can alter biomechanics in other patient populations, with ExFOCUS and auditory enhancing retention of learned biomechanics. Therefore, this randomized controlled trial will determine if a 4-week (12 session) impairment-based rehabilitation program that includes feedback (ExFOCUS or InFOCUS or Auditory) can (1) decrease ankle inversion kinematics and lateral plantar pressure during walking and (2) improve self-reported function.

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Key information

Conditions

Ankle Injuries Ankle Inversion Sprain Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Charlotte

Charlotte, North Carolina, 28223, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Characterized as having chronic ankle instability (CAI) by reporting a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI.
  • All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.

Exclusion criteria

  • Neurological or vestibular disorders affecting balance
  • Currently seeking medical care for CAI
  • History of ankle surgery
  • History of ankle sprain within the past 6 weeks
  • History of other musculoskeletal injuries within the past 6 weeks
  • Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function

Treatment and study plan

External focus of attention visual feedback

Other

Patients will receive external focus of attention visual feedback during the impairment-based rehabilitation program.

External focus of attention auditory feedback

Other

Patients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program.

Internal focus of attention video feedback

Other

Patients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program.

No feedback

Other

Patients will receive no feedback during the impairment-based rehabilitation program.

Primary outcomes

  1. Changes from baseline in lower extremity kinematics and kinetics during walking

    Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

    Ankle, knee, and hip motion and moments during walking measured by a 3D motion capture system and in shoe plantar pressure system

  2. Changes from baseline in self-reported ankle function

    Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

    Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sport questionnaire. Scores range from 100% (no decrease in function) to 0% (complete loss of function).

Secondary outcomes

  1. Changes from baseline in ankle range of motion measured in degrees

    Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

    Four different ankle ranges of motion will be measured

  2. Changes from baseline in ankle maximum voluntary isometric strength

    Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

    Ankle maximum voluntary isometric strength will be measured during four different ankle positions using a hand-held dynamometer.

  3. Changes from baseline in static and dynamic balance

    Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

    Static balance will be measured via a force plate and dynamic balance will be measured using the Star Excursion Balance Test

Sponsors and collaborators

Lead sponsor

University of North Carolina, Charlotte

Other

Registry information

Official study title

External Versus Internal Feedback on Biomechanics and Self-reported Function in Patients With Chronic Ankle Instability

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2019
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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